Cleared Traditional

K963703 - ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K963703 · International Biophysics Corp. · Cardiovascular device
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Apr 1998
Decision
569d
Days
Class 2
Risk

K963703 is an FDA 510(k) clearance for the ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000). Classified as Probe, Blood-flow, Extravascular (product code DPT), Class II - Special Controls.

Submitted by International Biophysics Corp. (Austin, US). The FDA issued a Cleared decision on April 8, 1998 after a review of 569 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2120 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all International Biophysics Corp. devices

Submission Details

510(k) Number K963703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1996
Decision Date April 08, 1998
Days to Decision 569 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
444d slower than avg
Panel avg: 125d · This submission: 569d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPT Probe, Blood-flow, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.